Safe and Secure. Use of Medicines Policy and

The content of the policies are uncontrolled when printed, check intranet for latest versions Procurement Return & Disposal Safe and Secure Ordering Issue to Patients Administration Use of Medicines Policy and Procedures Storage & Security Transport Prescribing If the policies are downloaded and / or printed then the responsibility lies with the individual practitioner to ensure they are accessing the most up to date policies. The content of the policies are uncontrolled when printed, check intranet for latest versions Approved by Safe Use of Medicines Issue August 2017 Page 1 of 164 Review Due: 01.03.18

Contents Definitions/ Standard Terminology... 9 Introduction and governance arrangements... 10 1. Definition of a medicine... 10 2. Policy Statements... 10 3. Aims... 11 4.Summary of the Procedure... 12 5. Queries... 12 1. Procurement of medicines from external suppliers... 13 1.1 Medical Representatives... 13 1.2 Medicine Samples... 13 1.3 Defective medicines... 13 1.4 Unlicensed medicines... 14 1.5 Medicines used for research and clinical trial... 15 2. Ordering and stock control in clinical areas in hospitals... 15 2.1 Stock lists... 15 2.2 Procedure for ordering medicines... 16 2.3 Procedure for receipt of medicines... 16 2.4 Arrangements for the supply of medicines when the pharmacy is closed... 17 2.5 Obtaining medicines from other wards, theatres and departments... 18 (See section 27.2.9 for Controlled Drugs)... 18 3. One Stop Dispensing... 18 3.2 Supplying medicines from the clinical area... 18 3.3 Over-labelled medicines... 19 3.4 Individual Patient Supply (IPS) medicines... 19 3.5 Unlabelled medicines... 19 3.6 Controlled Drugs... 20 3.7 Length of supply... 20 3.8 Re-labelling of Patients Own Medicines and Individual Patient Supply Medicines (IPS)... 20 3.9 Discontinued Medicines... 21 3.10 Transfer of patients medicines... 21 3.11 Discharge/pass medicines... 22 3.11.1 Discharge procedure... 22 3.11.2 Pass prescriptions... 22 3.11.3 Multi-compartment compliance aids (MCAs) e.g. Nomad box... 23 3.11.4 Medication Administration Records (MAR charts)... 23 3.11.5 Controlled Drugs... 23 3.11.6 Outwith pharmacy opening hours... 23 3.11.7 Respite Patients... 23 3.11.8 Unlabelled medicines... 24 3.11.9 Discharge/pass Prescription... 24 4. Use of patient s own medicines in hospitals... 24 4.1 Aims... 24 4.2 Pre-Admission... 24 4.3 Admission... 24 4.4 Consent... 24 4.5 Storage of Patients Own Medicines Medicine Cabinets... 25 4.6 Fridge Medicines... 25 4.7 Assessment of Patients Own Medicines... 25 4.8 Suitability criteria... 26 4.9 Use of multi-compartment compliance aids (MCAs)... 27 4.10 Unsuitable or discontinued patients own medicines... 28 4.11 Discrepancies between patients own medicines and the prescription chart... 28 5. Transport of medicines... 28 Approved by Safe Use of Medicines Page 2 of 164 Review Due: 01.03.18

5.1 Maintaining security and quality... 28 5.2 Maintaining the cold chain... 29 5.3 Use of courier/taxi by hospitals... 30 5.4 Delivery of medicines by NHS Fife staff or courier/taxi to patient s homes... 30 5.5 Posting medicines... 31 5.6 Return of medicines to the hospital pharmacy... 31 5.7 Transfer of medicines in hospitals or between hospitals... 31 6. Storage and Security in clinical areas including GP practices... 32 6.1 Standards for storage areas... 32 6.2 Control of access to medicines in hospitals / clinical areas... 35 6.3 Good practice in the storage of medicines... 37 6.4 Stationery Used to Order Medicines... 38 6.5 Prescription Pads... 39 6.6 Ward Closure... 39 7. Prescribing... 39 7.1 Authorisation... 39 7.2 Prescribing documents... 40 7.3 Hospital supplementary prescription and administration charts... 41 7.4 Prescription writing in hospital prescribing documents... 42 7.5 Prescriptions for inpatients (Booklet style)... 43 7.6 Prescriptions for inpatients using the Aberdeen Kardex - Mental Health Services... 44 7.7 Procedure for the transfer of drug prescriptions for NHS Fife Community Hospitals... 45 7.8 Prescription writing in community prescribing documents including prescription forms to be dispensed by a community pharmacist... 46 7.9 Prescribing in a multi-cultural, multi-faith society... 46 7.10 Prescribing for children... 47 7.11 Prescribing for older people... 47 7.12 Prescriptions for hospital discharge medicines... 47 7.13 Pass prescriptions... 48 7.14 Verbal prescription by a prescriber present at an emergency... 48 7.15 Remote Prescribing... 49 7.16 Patients with restricted oral intake... 49 7.17 Prescriptions for injections... 50 7.18 Fife Formulary... 51 7.19 Requests for non-formulary medicines in Managed Service... 52 7.20 Prescribing of Antimicrobials and Antimicrobial Stewardship... 53 7.21Supply to Podiatrists... 54 7.22 Administration of Medicines by Midwives under Medicines Act Exemptions (GL781)... 55 Policy Statement... 55 7.23 Optometrists and Orthoptists... 59 8. Prescribers that are not registered doctors, dentists or Foundation Year 1 (FY1) doctors... 60 8.1 Supplementary prescribing... 60 8.2 Suitable conditions and situations for safe and effective supplementary prescribing... 61 8.3Training and registration as a supplementary prescriber... 63 8.4 Steps in the process Preparation... 63 8.5 Steps in the process Operation... 64 8.6 Independent Prescribing Non-medical Prescribers Policy... 65 8.7 Training and registration as a non-medical independent prescriber... 66 8.8 Steps in the process... 67 9. Administration... 67 9.1 Practitioners authorised to administer medicines... 67 9.2 Administration of medicines in hospitals... 69 9.3 Management and Administration of Missed Doses... 70 9.4 Administration of medicines in patients own homes or homely setting... 71 Approved by Safe Use of Medicines Page 3 of 164 Review Due: 01.03.18

9.5 Administration by injection... 71 9.6 Administration to children under the age of 16 years in hospitals... 73 9.7 Covert administration of medicines... 73 9.8 Self-administration by patients in hospital not yet reviewed by a doctor... 75 9.8.1Emergency admissions... 75 9.8.2 Elective admissions... 75 10. Self-administration of medicines by patients in hospitals... 76 10.1 Introduction... 76 10.2 Aims of the self-administration programme... 76 10.3 Patient selection... 77 10.4 Teaching and supervision... 77 10.5 Assessment for Self-Administration Programme... 77 10.6 Consent and information sheet... 78 10.7 Levels of self-administration programme... 78 10.8 Storage of medicines... 78 10.9 Individual keys... 78 10.10 Management and Recording of Medicines Supplies... 79 10.11 Patient Care plan... 79 10.12 Multi-compartment compliance aids... 79 11. Patient Directions... 79 11.1Introduction... 80 12. Medicinal products that do not require a prescription or patient group direction or patient specific direction for administration... 80 13.Symptomatic Relief Policy (SRP) [For Adults Only]... 80 13.1 Introduction... 81 13.2 Procedure... 81 14. Issue of medicines for patients to take away from hospital... 82 14.1 Quantity supplied... 82 14.2 Supply standards... 82 14.3 Medicines issued when patients are discharged from hospital... 82 14.4 Procedure for supply of discharge / pass medicines when pharmacy is closed... 83 14.5 Pass prescriptions... 84 14.6 Procedure for supply of medicines to patients direct from Accident and Emergency Departments/Minor Injuries Units (MIU)... 84 14.7 Procedure for supply of medicines to outpatients direct from Outpatients / Day Care Areas.. 84 14.8 Prescribing in Fife Primary Care Emergency Service (PCES)... 85 14.9 Preparation of injections by patients and carers... 85 15. Return and disposal of medicines in hospital... 86 15.1 Return of medicines to the pharmacy... 86 15.2 Disposal of medicines... 86 15.3 Re-use of medicines... 87 16. Cytotoxic chemotherapy... 87 16.1 Abbreviated guidance on the safe administration of chemotherapy in non cancer areas including *azathioprine, ganciclovir, mycophenolate and valganciclovir... 87 16.1.1 Introduction... 87 16.1.2 Safe Practice Guidance... 88 16.1.3 Initiation of Chemotherapy Treatment in Non-Cancer Clinical Areas... 88 16.1.4 Identification of chemotherapy drugs... 88 16.1.5 Hospital Setting... 89 16.1.6 Community Setting... 89 16.1.7 Safe Handling Precautions... 90 17. Radiopharmaceuticals... 93 17.1 Transport... 93 17.2 Administration... 93 Approved by Safe Use of Medicines Page 4 of 164 Review Due: 01.03.18

17.3 Return and disposal... 94 18. Intrathecal Injections... 94 18.1 Introduction... 94 18.2 General good practice... 94 18.3 Arrangements for intrathecal spinal anaesthesia and analgesia... 95 18.3.1Personnel... 95 18.4 Arrangements for intrathecal injections other than spinal anaesthesia and analgesia... 96 18.4.1 Personnel... 96 18.4.2 Prescribing... 97 18.4.3 Preparation... 97 18.5 Issue and transportation from the pharmacy... 97 18.6 Timing of issue from the pharmacy... 98 18.7 Storage... 98 18.8 Administration... 98 19. Policy for the use of unlicensed and off-label medicines... 99 19.2 Completion of an unlicensed medicine / off label medicine request... 99 19.3 Protocol development for an unlicensed or off label medicine... 100 19.4 Emergency Request for an Unlicensed Medicine or a High-risk Off-Label Medicine... 100 19.5 Patient Consent... 100 19.6 Unlicensed / off-label medicines intended for long-term use.... 101 20. Medicines used for research and clinical trials... 101 20.1 Introduction... 101 20.2 Prescriptions for clinical trials... 102 21. Safe Storage and Use of Expired Drugs in Training... 102 21.1 Introduction... 102 21.2 Objectives... 102 21.3 Expired Drugs Held... 102 21.4 Issue by Pharmacy... 102 21.5 Receipt of Stock by the Trainer... 102 21.6 Security and Storage... 103 21.7 Disposal... 103 21.8 Record keeping... 103 22. Vaccination and immunisation... 103 22.1 Background... 103 22.2. General information for hospital staff... 103 23. Policies for specific medicines... 104 23.1 Potassium chloride injection... 104 23.2 Heparin (unfractionated) injection... 104 23.3 Midazolam injection... 105 23.4 Methotrexate... 105 23.5 Lithium... 105 23.6 Insulin... 105 23.7 Clozapine... 106 24. Donating medicines... 106 24.1 Introduction... 106 24.2 Guidance... 106 25. Medication Incidents... 107 25.1 Introduction... 107 26. Procedures for the preparation and administration of medicines... 109 26.1 Injections... 109 26.1.2 Intramuscular injection... 112 26.1.3 Subcutaneous Injection... 114 26.1.4 Intravenous Injection (bolus)... 115 26.2 Aural... 117 Approved by Safe Use of Medicines Page 5 of 164 Review Due: 01.03.18

26.3 Inhalation (Metered Dose Inhalers)... 118 26.4 Nasal... 120 26.5 Nebuliser... 121 26.6 Ophthalmic... 123 26.7 Oral... 125 26.8 Rectal... 127 26.9 Stomal... 131 26.10 Topical... 132 26.11 Transdermal... 133 26.12 Urinary Catheter... 135 26.13 Vaginal... 137 26.14 Enteral Feeds... 138 26.14.1 Introduction... 138 26.14.2 Medicines that interact directly with the enteral feed... 138 26.14.3 Medicines that interact with feeding tube... 139 26.14.4 Preparations that block the feeding tube... 139 26.14.5 Medicines that are sensitive to light... 139 26.14.6 Medicines that may require a change in dose/frequency/formulation... 139 26.14.7 Administration of medicines by feeding tube... 140 27. Controlled Drugs... 140 27.1 Management of CDs in GP Practice... 140 27.2 Management of CDs in Wards, Theatres and Departments (see section 27.3 for NHS Fife Out of Hours Emergency Service)... 140 27.2.1 CD Cupboards... 141 27.2.2 Management of CD Keys... 141 27.2.3 Missing CD Keys... 142 27.2.4 CD Stationery... 142 Definition of CD stationery... 142 Secure storage of CD stationery... 143 Supply of CD stationery... 143 Use of CD Record Book... 143 27.2.4.21 Missing CD Stationery... 144 27.2.5 CD Stocks... 145 27.2.6 Requistion / Order... 145 27.2.7 Ward / Department Stock... 145 27.2.8 Emergency Orders... 146 27.2.9 Use of Stocks from One Clinical Area in Another ClinicaL Area... 147 27.2.10 Supply and Transport of CDs from Pharmacy... 148 27.2.11 Receipt Of CDs... 148 27.2.12 Receipt of Patient s Own CDs... 149 27.2.13 Storage and Management of CDs in Wards and Departments... 149 27.2.14 CD Stock Checks... 150 27.2.15 CD Stock Checks by Pharmacy Staff... 151 27.2.16 Discrepancy and Diversion... 151 27.2.17 Prescribing for Inpatients... 151 27.2.18 Prescribing for Patients to be Discharged or Transferred... 151 27.2.19 Prescribing for outpatients... 152 27.2.20 Administration and Recording of CDs... 152 27.2.21 Self administration of CDs... 153 27.2.22 Transfer of Patient s Own CDs to another Hospital, Ward or Department... 153 27.2.23 Transferring Patients to another Clinical Area with CDs in Progress... 153 27.2.24 Management of CDs in Operating Departments and Theatres... 154 27.2.24.3 Supply of CDs to an Anaesthetist or Surgeon... 154 Approved by Safe Use of Medicines Page 6 of 164 Review Due: 01.03.18

See: Flowchart Procedure for Supply, Witnessing, Administration and Recording of Controlled Drugs in Theatre... 154 See: Flowchart Procedure for Supply, Witnessing, Administration and Recording of Controlled Drugs in Theatre Recovery... 155 27.2.25 Stock Checks In Operating Departments... 155 27.2.26 Disposal/Destruction of CDs... 155 27.2.27 Breakages and Spillages of CDs... 156 27.2.28 Procedure for Ward/Department Closures... 156 27.2.29 Procedure for Ward/Department Re-location... 157 27.2.30 CDs brought into hospital belonging to parents / carers... 157 27.2.31 Patients on prescribed methadone who are admitted or discharged from hospital... 158 27.2.32 Clinical Trials... 158 27.2.33 Suspicious Substances... 159 27.3 NHS Fife Primary Care Emergency Service (PCES)... 160 27.4 Domiciliary Settings... 160 27.4.1 Storage of CDs In Domiciliary Settings... 160 27.4.2 Transport of CDs In Domiciliary Settings... 160 27.4.4 Expired Stock, Stock No Longer Required in Domiciliary Settings (including hospital at home)... 161 28. Medical Gases... 162 29. Medicines Reconciliation... 162 30. References... 162 Approved by Safe Use of Medicines Page 7 of 164 Review Due: 01.03.18

List of additional documents included as hyperlinks Administration by Midwives Actions that can make anticoagulant therapy safer Adverse Events Policy Oral methotrexate in non-malignant conditions Checklist for Suspected Medicine Stock Discrepancy Control of Access to Medicines (Key custody) Flowchart Controlled Drug Accountable Officers' Network Scotland Example CD SOP Template for GPs - Non-Dispensing Fife Formulary Fife Formulary Paperwork and Submission Forms Missed Doses Flowchart Procedure for Supply, Witnessing, Administration & Recording of Controlled Drugs in Theatre Recovery Good Practice Guide Covert Medication Good Practice on Use of Concentrated Potassium Infusions Management of fine bore nasogastric feeding tubes guidance Administering medicines to patients with swallowing difficulties guidance Safe handling of intrathecal and intraventricular injections guidance Inaccessible Drug Cupboard-Flowchart Information for patients about the Self-Administration of Medicines Information on drugs used in emergency situations Medical Gases-Management of Key Replacement -Medicine Cupboard Request Form Medicine Reconciliation Medicines Fridges Mixing Medicines Antimicrobial Guide Adult Obtaining Informed Consent Policy Immunisation Procedure Fife Wide IR(ME)R Policy-Fife Wide Non - Medical Prescriber Registration Off-label or unlicensed use of medicines: prescribers responsibilities Patient Directions - Development,Review,Distribution Patient Self-Administration of Medicines Consent Form Potassium solutions: risks to patients from errors occurring during intravenous administration Preparation and use of Insulin and Insulin Infusions Prescription Writing Guidelines Prevention of Missed Doses Administering, Witnessing the Administration and Recording Administration of Controlled Drugs Flowchart Supply, Witnessing, Administration and Recording of Controlled Drugs in Theatre Flowchart Ward/Department Closure - Medicines procedure Reducing risk of overdose with midazolam injection in adults Restricted Antimicrobial List Rules for the sale, supply and administration of medicines for specific healthcare professionals Safer administration of insulin Safer lithium therapy Self Administration of Medicine Assessment Tool Shared Care Protocol-Lithium Administration of a Controlled Drug as a Titrated Dose in Theatre Recovery-SOP Medicines Fridges-SOP Handling requirements for selected CDs for NHS Fife Wards and Departments Supply of Medicines at point of Discharge when Pharmacy is Closed Symptomatic Relief Monographs Symptomatic Relief Policy Waste Management www.nmc-uk.org Approved by Safe Use of Medicines Page 8 of 164 Review Due: 01.03.18

Definitions/ Standard Terminology The terms below are used throughout the text for consistency and clarity. Slightly different titles may be used in practice in some areas for equivalent roles. the Board - NHS Fife Prescriber Doctor, dentist or non-medical prescriber responsible for a prescribing for a patient. Registered healthcare practitioner - nurse, midwife, health visitor, operating department practitioner or other registered healthcare practitioner, providing relevant competency is held. Healthcare Support Worker non-registered healthcare worker Senior Charge Nurse/ Team Leader is the senior nurse responsible for management of an area. In an area not managed by a nurse, this will be the equivalent senior registered healthcare professional who manages the area. Duty Senior charge nurse (DCN) - Nurse who is the first point of contact for dealing with problems out of hours (up to 7pm) that cannot be addressed at ward level. Clinical Co-ordinator Senior nurse on site out of hours, with site responsibility for managing operational and professional issues. On Call Manager - nominated senior manager who is on-call outside office hours who is the point of escalation for DCN/site co-ordinators. Pre-registration student a student nurse/ midwife/doctor/ dentist/ AHP. These individuals may take part in activities appropriate to their stage of learning, as agreed by their course tutors and local managers. This might include undertaking simple checking or witnessing administration or receipt of medicines. It does not include activities where supplementary training is required for registrants e.g. preparation of infusions. Prescription chart refers to the in-patient prescription chart and administration record (and relevant supplementary charts) used for the prescription and administration of medicines for inpatients. This may be either the common booklet style in acute areas and most community hospital settings, or the Aberdeen style used mainly in Mental Health areas. In community settings it refers to the combination of the prescription and any relevant administration record. Risk assessment There are several references to the need for a risk assessment to be completed. In most situations, particularly where the issue relates to an ongoing issue or is likely to recur, the expectation is that this will be a formal exercise fed through the line management system. In a few cases of immediate need in unusual circumstances it may be that a more informal process is appropriate, involving a review of the circumstances and possible risks with a colleague, and discussed with a line manager. Keys for Individual Patient Medicine Cabinets- each cabinet has a unique key, and the ward should hold a duplicate. Each ward should have a specified number of sub-master keys which will open all cabinets within that ward. Pharmacy should hold master keys which will open any cabinets. Approved by Safe Use of Medicines Page 9 of 164 Review Due: 01.03.18

Introduction and governance arrangements All areas where medicines are handled and used must have a system of procedures that meet legal requirements, that are in line with national guidance, and that ensure that risks to patients and staff are managed effectively. NHS Fife is responsible for establishing, documenting and maintaining an effective system to manage medicines safely and securely to meet patients clinical needs. This includes formal performance reporting systems, and a commitment to promote awareness of the significance of the system within the organisation. Medicines management is a multidisciplinary activity involving doctors, pharmacists, pharmacy technicians, nurses, Allied Health Professionals and managers as well as patients. There is a network of multi-professional committees and groups across primary and secondary care that support effective communication on medicines handling issues in Fife. This is a pan-nhs Fife policy designed to work within single system arrangements in Fife, and NHS Fife staff working in Health and Social Care areas are expected to comply. Local managers in clinical areas, and other departments where medicines are handled and used, are responsible for establishing and maintaining procedures that ensure safety, security and efficiency. The NHS Fife Safe Use of Medicines Policy provides a framework for the preparation of the required detailed local procedures which must be in line with this document. This should be used alongside relevant professional codes/ standards. Where the nurse in charge is named as the responsible person for certain elements of the system, the equivalent clinical manager or equivalent senior registered healthcare professional is the responsible person in areas where there is no senior charge nurse. 1. Definition of a medicine A medicine is a substance that is introduced into the body, or externally applied to the body that exerts a physiological change to the body. Medicines may be categorised as follows: Medicines and medicinal preparations which come under the provisions of the Human Medicines Regulations (2012). They include medicines used in clinical trials, unlicensed medicines, dressings, and medical gases. Controlled drugs i.e. substances controlled under the provisions of the Misuse of Drugs Act (1971) and Regulations made under the Act. Alternative medicinal products e.g. herbal or homeopathic remedies that are used for therapeutic purposes. 2. Policy Statements 1. All medicines administered or issued to NHS Fife patients are procured by and distributed through an NHS pharmacy, except for patients own medicines where their use is appropriate, or where distribution through a home delivery company is appropriate. 2. There are systems for the transport of medicines that ensure their security, quality and Approved by Safe Use of Medicines Page 10 of 164 Review Due: 01.03.18

integrity, and maintain the health and safety of the staff and the public 3. A record is kept at each step where a medicine changes hands, and when it is administered or destroyed. 4. Stock lists and stock levels of medicines for clinical areas are agreed and reviewed taking account of the requirement to have medicines available to meet patients needs, and to minimise the risks associated with administration. 5. Medicines are stored appropriately to maintain their quality and security. 6. All stationery used for ordering medicines is stored securely to prevent fraudulent use. 7. All incidents involving medicines, including a breach of the system of security of medicines, are investigated and reported in line with the NHS Fife Adverse Events Policy (GP/I9) 8. All medicines administered or supplied to patients are prescribed by an authorised prescriber, or are administered or supplied by an approved person operating within a patient group direction, recorded on approved forms. 9. Medicines are prescribed in line with the Fife Formulary, or have the required level of approval for use. 10. Unlicensed medicines, except for medicines being used for research or in clinical trials, are only used when no pharmaceutical equivalent of a licensed medicinal product is available. 11. Medicines are only administered or supplied to patients by suitably competent practitioners who can exercise professional accountability and judgment in the best interests of their patients. Self-administration schemes incorporate formal patient assessment. 12. Disposal of medicines complies with legal requirements and health and safety regulations. 3. Aims 1. To ensure that medicines are of the required quality. 2. To maintain clinical effectiveness and minimise risk to patients by ensuring that medicines are available at the time they are needed. 3. To ensure that medicine stocks are kept at an appropriate range and level to minimise wastage and are in line with the recommendations and policies of the Formulary Committee, Managed Service Drugs and Therapeutics Committee (MSDTC) and Area Drug and Therapeutics Committee (ADTC). 4. To maintain clinical effectiveness and minimise risk to patients. 5. To ensure that the quality and security of medicines is maintained during Approved by Safe Use of Medicines Page 11 of 164 Review Due: 01.03.18

transportation and that they are transported with due attention to health and safety considerations. 6. To ensure that the security and quality of medicines is maintained in all areas where medicines are stored or administered within NHS Fife premises, or where they are issued to midwives, community nurses and ambulance officers for storage and use outwith NHS Fife premises. 7. To ensure that all prescriptions for medicines are written according to accepted NHS Fife standards and legal requirements. 8. To minimise the risk of errors with the prescribing, administration and supply of medicines. 9. To maintain an accurate record of the medicines prescribed, administered and supplied to all patients. 10. To dispose of unwanted medicines safely. 11. To minimise wastage of medicines. 4.Summary of the Procedure Procedures to support the policy are available below and on the NHS Fife intranet If the policies are downloaded and / or printed then the responsibility lies with the individual practitioner to ensure they are accessing the most up to date policies. The content of the policies are uncontrolled when printed, check intranet for latest versions 5. Queries Any questions regarding the content of this document should be raised in the first instance with your line manager, and can be escalated through the relevant line management structure as appropriate. Any member of the Review will also be pleased to discuss any problems that may arise with the implementation or the interpretation of the policies where required. Contacts: A Timmins, Principal Pharmacist, Acute Services Division M Vass, Pharmacy Technician Team Leader, Community Services, HSCP K Brechin, Head of Nursing, Acute Services A Duthie, Senior Nurse, Mental Health Services, HSCP K Gibb, Lead Nurse, Cameron Hospital, HSCP K Robertson, Lead Nurse, West Division, HSCP T Anderson, Lead Nurse East Division, HSCP A Lawrie, Head of Midwifery/Nursing Planned Care, Acute Services Division G Smith, CD Pharmacist, Pharmacy Services, HSCP Approved by Safe Use of Medicines Page 12 of 164 Review Due: 01.03.18

1. Procurement of medicines from external suppliers 1.1 Medical Representatives 1.1.1 Company medical representatives must observe the ABPI (Association of British Pharmaceutical Industry) Code of Practice for the Pharmaceutical Industry in the promotion of medicines. Working with the Pharmaceutical Industry and Healthcare Equipment Suppliers 1.1.2 The presence of medical representatives must not disrupt work in clinical areas or in general practice. 1.1.3 NHS Fife staff may not be approached directly by medical representatives. Only appropriate appointed staff for example consultants, specialist registrars, senior charge nurses, nurse specialists and pharmacy staff should see representatives by appointment only. 1.1.4 Offers of hospitality (including the payment of travelling or accommodation expenses) from medical representatives for meetings or events for professional or scientific purposes, or for the promotion of a medicinal product may only be accepted if the hospitality is strictly limited to the main purpose of the meeting or event, and the person accepting the hospitality is a health professional. NHS Fife employees must follow relevant guidance and policies regarding business conduct. 1.1.5 The Director of Pharmacy or delegated deputy is involved in all negotiations with suppliers for agreements and contracts for medicines used in hospitals, including companies that deliver medicines directly to a patient s home. Representatives must not negotiate agreements or contracts for medicines without involving the Director of Pharmacy or delegated deputy. 1.1.6 Hospital staff must not disclose information on medicine costs to representatives. Information on hospital medicine costs and prices is confidential within NHS Fife and is only referred to in the most general terms to non-nhs Fife personnel, except during direct negotiations of agreements and contracts which should only be undertaken by authorised staff. 1.2 Medicine Samples 1.2.1 NHS Fife staff (other than pharmacy) must not accept any product, including medicines or dressings, from medical representatives. Exceptions are placebo/dummy products for training purposes only. 1.3 Defective medicines 1.3.1 Official notification of a defective medicine is issued from the Scottish Government as a Drug Alert, or from the manufacturer or supplier. Scottish Government Drug Alerts include the required timescale for action. Approved by Safe Use of Medicines Page 13 of 164 Review Due: 01.03.18

1.3.2 The Director of Pharmacy must ensure that there are systems in place to check if the defective medicine has been issued for use in NHS Fife, to alert clinical staff and to withdraw from use any defective medicine that has been issued, within the required timescale for action. Dissemination of Scottish Government Medicine Directives (Drug Alerts, Drug Safety Information & Immediate/Urgent messages) 1.3.3 Defective medicines or potentially defective medicines must be withdrawn from use in the defined timescale to minimise risk to patients. 1.3.4 If any member of staff or contractor has reason to believe that a medicine is defective, he or she must inform a pharmacist immediately. The pharmacist is responsible for taking appropriate action including completion of a DATIX report if applicable. See section 25. 1.3.5 The person who discovers the defect must ensure that the product, container and other packaging are retained. If the defect has been discovered following reconstitution or mixing with another preparation, then the mixture, remaining unmixed constituents, and all containers and other packaging must also be retained. All retained materials must be placed in a sealed container, clearly marked Do not use, and returned to the pharmacy as soon as possible. 1.3.6 The Director of Pharmacy must ensure that there are systems in place to investigate local reports of defective medicines, to withdraw from use other affected stock if appropriate, and to inform the Scottish Government, Pharmacy Division, if there are implications for the rest of the health service. 1.3.7 If there is a reason to believe that a device is defective then a DATIX incident will be raised and NHS Fife adverse events policy is followed. Adverse Events Policy 1.4 Unlicensed medicines 1.4.1 Licensed medicines are medicines that have a UK Marketing Authorisation, formerly called a Product Licence, issued by the Medicines and Healthcare products Regulatory Agency (MHRA). 1.4.2 Wherever possible licensed medicines must be used to treat patients. 1.4.3 Unlicensed medicines are medicines that do not have a Marketing Authorisation. They include: Medicines not for sale in the UK, for example awaiting a UK Marketing Authorisation, undergoing clinical trial, withdrawn from the market or manufactured out-with the UK. These medicines are usually available on a named patient or individual patient basis. Medicines prepared by a hospital or commercial manufacturer under a specials licence. These medicines are termed pharmaceutical specials. Medicines prepared for a specific patient in accordance with an individual prescription. These medicines are termed extemporaneously dispensed medicines. Licensed medicines repacked from their original containers in batches rather than for an individual patient. 1.4.4 Appropriate risk management arrangements must be followed for the procurement of medicines that do not have a Marketing Authorisation. 1.4.5 All independent prescribers can prescribe unlicensed medicines that have been approved by Approved by Safe Use of Medicines Page 14 of 164 Review Due: 01.03.18

NHS Fife Area Drug and Therapeutics Committee, pharmacy can dispense them, and all registered practitioners can administer them to patients. If the medicine is to be used to treat an individual patient, and it has not been approved for use by the Area Drug and Therapeutics Committee, the policy for obtaining approval for an unlicensed medicine must be followed. If a prescriber wishes to initiate new treatments for groups of patients or individual patient using an unlicensed medicine, a request must be submitted to the Managed Service Drug and Therapeutics Committee. Where an unlicensed medicine is required for an individual patient on compassionate grounds the clinical pharmacist must be contacted for further guidance. See Section 19- Policy for the use of unlicensed and off-label medicines 1.4.6 The prescriber is responsible for ensuring that the use of an unlicensed medicine is clearly justified and that the benefits are considered to outweigh the risks and that this has been discussed and agreed with the patient and recorded in the patients notes. 1.4.7 The pharmacist is responsible for ensuring, as far as possible, that the medicine he or she supplies is used safely, effectively and appropriately, and is suitable for the patient. 1.4.8 The Director of Pharmacy must ensure that there are systems in place to procure unlicensed medicines of the required quality. 1.5 Medicines used for research and clinical trial 1.5.1 See section 20- Medicines used for research and clinical trials. 2. Ordering and stock control in clinical areas in hospitals 2.1 Stock lists 2.1.1 The senior charge nurse and the responsible pharmacist must agree a stock list that reflects the needs of the patient group in each clinical area, and is in line with agreed formularies. The stock list must be reviewed and updated regularly, at least once every year. 2.1.2 Staff must be trained and competent to handle and administer all the medicines on the agreed stock list 2.1.3 The stock list must contain a list of the names and forms of all medicines required, and the minimum stock level that must be held. 2.1.4 Arrangements must be in place to encourage patients to bring their own medicines for use during the hospital stay. 2.1.5 Arrangements must be in place to ensure that medicines that are not included in the agreed stock list, or where the patient s own supply is not available or suitable, are obtained timeously, so that doses are not missed or delayed. 2.1.6 Arrangements must be in place to ensure that appropriate support and training is available and accessible to staff for medicines that are not regularly used in that area. Approved by Safe Use of Medicines Page 15 of 164 Review Due: 01.03.18

2.2 Procedure for ordering medicines (See Section 27 for Controlled Drugs) 2.2.1 The senior charge nurse, the responsible pharmacist or pharmacy technician, and the porters manager must agree a schedule for ordering and delivery of medicines. 2.2.2 Medicines included in the stock list must be ordered so that they may be delivered according to the schedule. Non- stock items can be ordered at any time but where possible should be ordered at the same time as stock list items. 2.2.3 Ward staff must arrange delivery for items that are ordered outwith the normal delivery schedule. 2.2.4 The senior charge nurse must ensure that medicines are only ordered by registered nursing staff or other relevant professionals that the SCN has authorized. It is the responsibility of the SCN to ensure that authorised staff are trained and competent in the processes involved in ordering medicines. 2.2.5 Staff who order medicines must make all the checks that are needed to ensure that only medicines that are required are ordered. Patients should use their own medicines during the hospital stay when they are suitable, and with patient consent. See section 4 Use of patient s own medicines in hospital. 2.2.6 Medicines must be ordered from the pharmacy on approved ordering documents. 2.2.7 All required information must be written clearly on the ordering document. 2.2.8 The senior senior charge nurse must monitor medicines ordering practice to ensure that it is carried out efficiently, so that doses are not missed or delayed unnecessarily, medicines are not wasted, and medical, nursing, pharmacy and portering time is used efficiently. 2.2.9 If a medicine is not available, this must be recorded clearly on the prescription record, documented in the patient s medical record, and the responsible doctor informed as in the flow chart for missed doses. Flowchart Missed Doses 2.3 Procedure for receipt of medicines 2.3.1 Medicines must be issued from the pharmacy in a tamper evident package, clearly labeled with the destination, and accompanied by a note of what has been supplied. Tamper evident packaging and a note of what has been supplied are not required when medicines are collected by the patient. 2.3.2 The messenger or porter who collects the completed order from the pharmacy must sign for receipt of the sealed package. 2.3.3 A registered healthcare professional must sign for receipt of the sealed package in the ward, theatre or department. Approved by Safe Use of Medicines Page 16 of 164 Review Due: 01.03.18

2.3.4 If the order cannot be checked immediately, the registered healthcare professional is responsible for ensuring that the package is stored in the conditions necessary to maintain security and quality (for example, in a locked area or under surveillance or in a locked fridge if required). 2.3.5 A registered healthcare professional in the ward, theatre or department, must check the received order, as follows. The package is sealed and has not been tampered with. The items listed on the note of what has been supplied match the items that were ordered. The items listed on the note of what has been supplied match the items that have been received. 2.3.6 If a discrepancy is found it must be reported to the pharmacy immediately so that it can be investigated. A DATIX report must be completed by the person discovering the discrepancy. 2.3.7 The note of what has been supplied must be retained in the ward, theatre or department for 2 years, or for prescriptions, in the patient s medical notes. (7 years for controlled drug record books) 2.3.8 The appropriate registered healthcare professional is responsible for ensuring that all medicines that are not required for immediate administration are placed at the correct location in a suitably secure storage area immediately on receipt. 2.3.9 Receipt of controlled drugs- see Section 27 2.4 Arrangements for the supply of medicines when the pharmacy is closed 2.4.1 The senior charge nurse is responsible for ensuring that all required medicines are available so that doses are not missed or delayed unnecessarily. There must be a system in place to ensure that adequate supplies of required medicines are ordered during the pharmacy opening hours. 2.4.2 The responsible lead pharmacist must ensure that an adequate supply of the agreed list of medicines that may be required in an emergency is maintained in the emergency cupboard at VHK, QMH and Stratheden, when the pharmacy is closed. The duty charge nurse, senior charge nurse responsible for the site, or Hospital at Night co-ordinator must have access to the emergency cupboard. 2.4.3 The responsible lead pharmacist must ensure that an on-call pharmacist is available to provide advice on availability and safe use of medicines when the pharmacy is closed, and to provide urgently required medicines from the pharmacy if necessary. 2.4.4 The on-call pharmacist must be able to be available in the site pharmacy if required within one hour of a call being received. 2.4.5 If a prescribed medicine is not available in the clinical area when the pharmacy is closed, the senior charge nurse must take action as follows. consult with the prescriber to agree whether the dose may be missed or delayed without compromising patient care, until the pharmacy is open. If not, Approved by Safe Use of Medicines Page 17 of 164 Review Due: 01.03.18

consult with the prescriber to agree whether an alternative medicine that is available can be prescribed and administered, without compromising patient care. If not, contact the senior nurse/ clinical co-ordinator responsible for the site. 2.4.6 Depending on the arrangements at the site concerned, the nurse responsible for the site should contact the on-call pharmacist. The co-ordinator responsible for the site is the first point of contact for ward staff before the on-call pharmacist is contacted. 2.4.7 The nurse responsible fo the site must check ward and emergency cupboard stock lists that are available and arrange for medicines to be obtained if appropriate. If the medicine is not available to obtain, or if it is not appropriate to obtain the medicine, and if the medicine is required before the pharmacy opens, the nurse responsible for the site or must contact the oncall pharmacist. 2.4.8 The on-call pharmacist must take action as follows. If the medicine is not stocked in another ward or department and another medication is not appropriate, and the medicine is stocked in the pharmacy, if deemed clinically appropriate, the on-call pharmacist will attend the hospital to supply. If the medicine is not stocked in the pharmacy, discuss with the prescriber and agree appropriate action. 2.5 Obtaining medicines from other wards, theatres and departments (See section 27.2.9 for Controlled Drugs) 2.5.1 Medicines may only be obtained from other wards, theatres and departments when the pharmacy is closed or in a clinical emergency. 2.5.2 The pharmacy order book must be completed for all medicines obtained whether full packs or single doses, clearly stating the issuing and receiving wards, theatres or departments, and signed by the nurses issuing and receiving, and detailing the quantity. A copy of the form must be retained in the supplying area, so that replacement or further supplies may be ordered when the pharmacy opens. A copy must also be sent to the pharmacy so that costs may be recharged and a record held. 2.5.3 Loose tablets or strips must not be transferred. Normally a full pack should be supplied to the receiving ward to ensure all relevant product information is available. If this is not possible (eg due to insufficient stock), the pack should be taken to the requesting area, the dose is administered, then the pack is returned to the original ward. 3. One Stop Dispensing 3.1 One Stop Dispensing refers to the practice of combining inpatient and discharge dispensing into a single supply labeled for discharge. 3.2 Supplying medicines from the clinical area 3.2.1 Patients will use their own medicines brought in from home if they are in a suitable condition and they will be assessed for use using the suitability criteria (See Section 4 Use of Patients Own Medicines). Approved by Safe Use of Medicines Page 18 of 164 Review Due: 01.03.18

3.2.2 It may be necessary to supply medicines for inpatient use for the following reasons; Patients Own Medicines are unsuitable Patients Own Medicines have not been brought in A further supply of a Patients Own Medicine is required A new medicine has been started The patient does not consent to the use of their medicines during their hospital stay 3.2.3 Supplying a medicine for inpatient use can be done in one of three ways: As an over-labelled medicine from the ward pre-labelled medicine supply As an Individual Patient Supply (IPS) ordered from pharmacy As an unlabelled medicine from ward stock 3.2.4 Outside pharmacy opening hours, if a patient requires a supply of a medicine that is not available on the ward, the procedure for missed doses should be followed Flowchart Missed Doses If the prescriber advises that a dose is essential, and there are no alternative sources in the hospital, the pharmacist on call may be contacted through the hospital co-ordinator. If the pharmacist is able to make an emergency supply, this will normally be as an unlabelled pack (see 3.5). The pack can be labelled during normal pharmacy hours. 3.3 Over-labelled medicines 3.3.1 The clinical pharmacist for each ward will agree a list of medicines that are commonly used in the clinical area. Pharmacy will then supply these medicines to the ward as over-labelled medicines (pre-packs). 3.3.2 All over-labelled medicines will have blank spaces for the patients name and date. They may have a standardised instruction on the label, printed on the container, or there may be spaces for instructions to be added. The patient name, date and instruction (where appropriate) must be completed on discharge, pass, transfer to another hospital by ward nursing staff, or if the patient is self-administering. 3.4 Individual Patient Supply (IPS) medicines 3.4.1 Medicines that are not supplied to the ward as an over labelled medicine (pre-pack), but are required for a patient must be ordered from pharmacy. They must be ordered using the Request for Individual Patient Supply order form, which is classified as controlled stationery so must be stored securely. A registered nurse, pharmacist or pharmacy technician can copy prescription details from the prescription and administration chart on to the Individual Patient Supply form. This request must be checked and signed by a second person who may be a registered nurse, pharmacist, or pharmacy technician. 3.5 Unlabelled medicines 3.5.1 All wards will have a supply of unlabelled medicines. Unlabelled medicines can be used when: Approved by Safe Use of Medicines Page 19 of 164 Review Due: 01.03.18

An over-labelled medicine supply is unavailable An individual patient supply is ordered but has not yet arrived An as required or once only dose is required 3.5.2 They can be placed in the patients medicine cabinet temporarily, until labeled stock can be obtained. Unlabelled medicines must never be sent home with a patient. 3.6 Controlled Drugs 3.6.1 Controlled Drugs are not currently included in the One Stop Dispensing scheme. If a supply of controlled drugs is required for a patient they can be ordered for ward stock from pharmacy in the usual manner. When ordered individually for the patient for discharge or pass they must be ordered on a standard prescription, and the prescriber s hand-written signature is required. All Controlled Drugs must be stored in the ward CD cupboard and recorded in the CD Record Book. See: Summary of handling requirements for selected CDs for NHS Fife Wards and Departments 3.7 Length of supply 3.7.1 Over-labelled medicines (Pre-Pack) and Individual Patient Supply (IPS) medicines will be issued as a 28 day supply or the nearest original pack size. If the medicine regime requires a lesser supply these can be issued in one of two ways: By using the IPS system to obtain the desired quantity. This is the preferred arrangement to ensure patients have the correct supply of medication to complete the prescribed course (e.g. antibiotics, steroids). By issuing a full pack and giving the patient clear instructions on the length of supply to be administered. The patient should also be advised to return any excess medicine/s to their community pharmacy for disposal. This option should only be considered when the registered healthcare professional supplying the medication for discharge is confident that the patient or relative clearly understands the instructions and advice given. 3.8 Re-labelling of Patients Own Medicines and Individual Patient Supply Medicines (IPS) 3.8.1 The instructions on the label of medicines supplied to a patient should always correspond to those on the prescription and administration chart. If a dose on a prescription and administration chart is changed from the GP prescription, the correct dose should be supplied by using a pre-labelled medicine from the ward or by ordering from pharmacy as an IPS. If relabeling of an IPS medicine is required this can only be done by clinical pharmacy staff who should be contacted. 3.8.2 Administration of medicines on the ward may still be carried out in accordance with instructions on the prescription and administration chart, even if the directions on the label are Approved by Safe Use of Medicines Page 20 of 164 Review Due: 01.03.18

incorrect as long as the drug is suitable for use and the appropriate dose can be administered. Patients must not be discharged home with incorrect instructions on medicines. Such medicines must be relabelled prior to discharge. 3.8.3 All patients own drugs and medicines issued by the hospital may be re-labelled. If re-labelling patients own medicines the name of the original dispensing pharmacy must remain visible. Re-labelling must only be carried out by a member of pharmacy staff. 3.9 Discontinued Medicines 3.9.1 Patients Own Medicines no longer prescribed must be removed from the patients medicine cabinet. If it is suspected that the patient may re-start the medicine, it may be stored in the patient s medicine cabinet or ward drug cupboard for a short period of time before being returned to pharmacy for destruction (with patient s consent) if no longer required. 3.9.2 Over-labelled medicines may be considered for return to ward supply if they have not previously left the hospital, and have not been endorsed with the patient s name, date of issue or instructions. Any discontinued IPS medicines must be returned to pharmacy for destruction. 3.10 Transfer of patients medicines Patient details and instructions are added to over-labelled packs only when the patient is going out on pass, being discharged or being transferred to another hospital or healthcare setting. 3.10.1 Transfer within a ward If a patient is being transferred to a different bed within the same ward, nursing staff are responsible for ensuring that all medicines are removed from the patients medicine cabinet, taken to the new bedspace and locked in the appropriate patient medicine cabinet. 3.10.2 Transfer within the same hospital All medicines must be removed from a patient s cabinet, by the nurse, and taken to the new ward or bed in the designated green medicine bag. Nursing staff at the receiving ward are responsible for ensuring medicines are received and must check them against the patients prescription and administration chart to ensure the supply is correct. 3.10.3 Transfer to another hospital Patients transferred to another hospital, within or out-with NHS Fife, should be regarded as being discharged from the ward. Appropriate transfer documentation, including a clear list of current medicines and recent changes, must be provided along with all necessary medicines. 3.10.4 Emergency transfer If a patient is being transferred to another hospital as an emergency, then a discharge prescription is not required. A copy of the current prescription and administration chart must be sent with the patient along with all currently prescribed medicines from the patients medicine cabinet or medicine trolley. Any fridge items and patients own controlled drugs must also be included. 3.10.5 Individual medicine cabinet check When a patient has been moved from a bedspace, the bedside medicines cupboard must be emptied, cleaned and checked before another patient is admitted to this bedspace. Approved by Safe Use of Medicines Page 21 of 164 Review Due: 01.03.18